Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tandemact   
Auth. number : EU/1/06/366
INN : Pioglitazone / Glimepiride
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BD - Combinations of oral blood glucose lowering drugs
Chemical substance: A10BD06 - Glimepiride and pioglitazone
(See WHO ATC Index)
Indication: Tandemact is indicated as second line treatment of adult patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Marketing Authorisation Holder: Takeda Pharma A/S
Langebjerg 1, DK-4000 Roskilde, Danmark

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/01/2007 Centralised - Authorisation EMEA/H/C/680 (2007)73 of 08/01/2007
23/03/2007 Centralised - Variation EMEA/H/C/680/IA/1
23/04/2007 Centralised - Variation EMEA/H/C/680/IB/3
23/04/2007 Centralised - Variation EMEA/H/C/680/IB/2
15/06/2007 Centralised - Variation EMEA/H/C/680/IA/7
29/08/2007 Centralised - Variation EMEA/H/C/680/II/4 (2007)4078 of 27/08/2007
14/11/2007 Centralised - Variation EMEA/H/C/680/II/5 (2007)5545 of 12/11/2007
04/12/2007 Centralised - Variation EMEA/H/C/680/II/8, 9 (2007)6087 of 30/11/2007
13/12/2007 Centralised - Variation EMEA/H/C/680/II/10 (2007)6415 of 11/12/2007
02/04/2008 Centralised - Variation EMEA/H/C/680/X/6 (2008)1284 of 31/03/2008
08/07/2008 Centralised - Variation EMEA/H/C/680/IA/11
09/07/2008 Centralised - Variation EMEA/H/C/680/IA/13
29/07/2008 Centralised - Variation EMEA/H/C/680/IB/14
29/07/2008 Centralised - Variation EMEA/H/C/680/IB/12
29/07/2008 Centralised - Variation EMEA/H/C/680/IB/15
23/02/2009 Centralised - Variation EMEA/H/C/680/IA/16
Updated with Decision(2009)6749 of 31/08/2009
27/03/2009 Centralised - Variation EMEA/H/C/680/IB/17
Updated with Decision(2009)6749 of 31/08/2009
02/09/2009 Centralised - Variation EMEA/H/C/680/II/18 (2009)6749 of 31/08/2009
09/09/2009 Centralised - Variation EMEA/H/C/680/N/19
Updated with Decision(2010)2022 of 23/03/2010
25/03/2010 Centralised - Variation EMEA/H/C/680/II/20 (2010)2022 of 23/03/2010
14/09/2010 Centralised - Variation EMEA/H/C/680/IB/21/G
28/12/2011 Referral EMEA/H/C/680/A-20/22 (2011)10088 of 22/12/2011
29/12/2011 Referral EMEA/H/C/680/A-20/22 (2011)10087 of 22/12/2011
06/03/2012 Centralised - Renewal EMEA/H/C/680/R/23 (2012)1495 of 02/03/2012
17/01/2013 Centralised - Variation EMEA/H/C/680/WS/324 (2013)211 of 14/01/2013
24/04/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/680/T/30 (2013)2408 of 22/04/2013
15/11/2013 Centralised - Modification EMEA/H/C/680/PSUV/33 (2013)8073 of 13/11/2013
23/07/2014 Centralised - Variation EMEA/H/C/680/IB/37/G